Inspections, Compliance, Enforcement, and Criminal Investigations

Repromed Fertility Center 7/28/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

July 28, 2014
 

Ref: 2014-DAL-WL-15
 

WARNING LETTER

UPS OVERNIGHT MAIL

Anil B. Pinto, M.D., PA
Owner
Repromed Fertility Center
3800 San Jacinto St.
Dallas, Texas 75204

Dear Dr. Pinto:

The Food and Drug Administration (FDA) conducted an inspection of your firm, Repromed Fertility Center located at 3800 San Jacinto St., Dallas, Texas, from March 27 through April 2, 2014. During this inspection, the FDA investigator documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations, Part 1271 (21 CFR 1271), and issued under the authority of Section 361 of the Public Health Service Act (42 USC§ 264).

The deviations documented on the Form FDA 483, lnspectional Observations (FDA 483), were presented to and discussed with you at the conclusion of the inspection. The items of concern include, but are not limited to, the following:

1.    Failure to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor; or up to seven days before or after recovery [21 CFR 1271.80(b)]. Specifically,

Your firm failed to collect a communicable disease specimen for directed semen donor (b)(6) within seven days before or after recovery. A blood specimen was collected for testing on January 30, 2013, and the semen was recovered on February 28, 2013.

2.    Failure to screen a donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)].

Your firm failed to conduct physical assessments, review or complete the Donor Medical History Interview forms and/or Donor Physical Assessment forms prior to determining donor eligibility. Incomplete Donor Medical History Interview form(s) and/or Donor Physical Assessment form(s) were used to determine and approve donor eligibility. Specifically,

a)    Failure to conduct a physical assessment for directed semen donor (b)(6).
b)    Failure to complete the Donor Medical History Interview form, for example:

i.    The August 20, 2013 form for anonymous oocyte donor (b)(6) was incomplete. Oocytes were recovered on September 2, 2013.
ii.    The March 2, 2013 form for anonymous oocyte donor (b)(6) was incomplete. Oocytes were recovered on March 11, 2013.
iii.    The January 14, 2013 form for anonymous oocyte donor (b)(6) was incomplete. Oocytes were recovered on January 24, 2013.
iv.    The August 5, 2013 form for anonymous oocyte donor (b)(6) was incomplete. Oocytes were recovered on August 29, 2013. 

c)    Failure to complete the Donor Physical Assessment form, for example:

i.    The January 3, 2012 form for anonymous oocyte donor (b)(6) was incomplete. Oocytes were recovered on January 28, 2012.
ii.    The February 13, 2013 form for directed oocyte donor (b)(6) was incomplete. Oocytes were recovered on February 28, 2013.
iii.    The October 13, 2012 form for anonymous oocyte donor (b)(6) was incomplete. Oocytes were recovered on January 24, 2013.

3.    Failure to determine whether a donor is eligible based upon the results of donor screening in accordance with CFR 1271.75, and donor testing in accordance with CFR 1271.80 and 1271.85. A responsible person must determine and document the eligibility of a cell or tissue donor [21 CFR 1271.50(a)]. Specifically,

Your firm determined donor eligibility prior to the receipt of donor testing results, for example:

a)    A communicable disease specimen was collected for testing on August 5, 2013 for anonymous oocyte donor (b)(6). Your firm determined the donor to be eligible on August 5, 2013. Test results were reported on August 7, 2013. Oocytes were recovered on August 29, 2013.

b)    A communicable disease specimen was collected for testing on December 31, 2012 for anonymous oocyte donor (b)(6). Your firm determined the donor to be eligible on January 2, 2013. Test results were reported on January 4, 2013. Oocytes. were recovered on January 24, 2013.

c)    Anonymous oocyte donor (b)(6) whose Donor Physical Assessment form was dated October 10, 2013; however, the donor eligibility determination was dated September 25, 2013. Oocytes were recovered on October 16, 2013.

The deviations identified above are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all applicable requirements of the federal regulations. You are responsible for reviewing your firm's operations as a whole to assure that you are in compliance with all of the FDA regulatory requirements.

We acknowledge receipt of your written response dated April 14, 2014. We have reviewed the corrective actions summarized in your response and we have determined that the response is inadequate to address our concerns. Your response addresses only prospective changes to your practices and does not address donor screening and relevant communicable disease testing for all previous anonymous and directed HCT/P donors for whom screening and/or testing was not adequately performed. You also did not address the increased risk of communicable disease transmission for HCT/Ps remaining in storage at your firm.

You should take prompt action to correct the violations addressed in this letter and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. If corrective action cannot be completed within (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.

Your response should be sent to Thao Ta, Compliance Officer, Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at (214) 253-5217.
 

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director

Page Last Updated: 12/16/2014
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